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Completed

NCT Number: NCT05862857

The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 1)

This study will test innovative interventions to increase uptake and use of biomedical HIV prevention options by engaging women and men at drinking venues in rural Kenya and Uganda in care, while gaining insights into the facilitators, barriers, and cost-effectiveness of these approaches.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kenya Medical Research Institute (KEMRI), Mbita, Kenya

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About this study

[BACKGROUND] Alcohol use is a common risk factor for both HIV prevention uptake and retention in sub-Saharan Africa (SSA). Interventions that promote biomedical HIV prevention (PrEP and PEP) among persons with heavy alcohol use and their sexual partners are urgently needed. Alcohol-serving drinking venues play an important role as sites of HIV transmission in SSA and are ideal sites to engage women and men at increased risk of HIV in biomedical prevention services.

[OVERVIEW] The investigators have developed a mobilization strategy of integrating HIV testing within multi-disease screening to recruit >2,000 people from drinking venues in Kenya and Uganda. The investigators now need to determine whether multi-disease mobilization can promote uptake of HIV prevention for adults at drinking venues in the context of new biomedical prevention options.

The project will rigorously test innovative interventions in Kenya and Uganda to increase uptake of biomedical HIV prevention, and assess facilitators, barriers, and cost-effectiveness of these approaches.

Specific Aims:

  • Compare the effectiveness of two mobilization strategies to increase uptake of biomedical HIV prevention among adults at drinking venues.
  • Determine the cost-effectiveness of interventions that increase biomedical HIV prevention uptake among adults at high-risk for HIV who attend drinking venues.

The proposed research will address the critical intersection of alcohol use and HIV risk in SSA, by promoting reach and uptake of biomedical HIV prevention and exploring associated facilitators and barriers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Participant Inclusion Criteria:

  • adult (≥18 years)
  • patron or worker at a drinking venue within the study community

Exclusion criteria

  • none

Treatment and study plan

HIV-focused mobilization

Behavioral

Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free HIV testing at the local clinic

Multi-disease-focused mobilization

Behavioral

Patrons and employees of drinking venues that are randomized to HIV-focused recruitment will receive a recruitment card offering free health screenings that may include hypertension, diabetes, HIV, malaria (if febrile), and TB (if symptomatic), and pregnancy at the local clinic

Primary outcomes

  1. Biomedical HIV Prevention Uptake at 4 Weeks

    Time frame: Measured 4 weeks after clinic screening visit

    The proportion of HIV-negative adults, receiving an Aim 1 mobilization card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues).

Secondary outcomes

  1. Biomedical HIV Prevention Uptake at 8 Weeks

    Time frame: Measured 8 weeks after clinic screening visit

    The proportion of HIV-negative adults, receiving an Aim 1 mobilization card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues).

  2. Biomedical HIV Prevention Uptake at 12 Weeks

    Time frame: Measured 12 weeks after clinic screening visit

    The proportion of HIV-negative adults, receiving an Aim 1 recruitment card, who initiate PrEP or PEP after mobilization. This outcome will be measured by pill dispensing records and Ministry of Health (MoH) PrEP and PEP registry records. Mean was calculated as the average percentage across the clusters (groups of nearby alcohol-serving venues).

  3. HIV Testing Uptake

    Time frame: Measured at clinic screening visit

    The proportion of HIV-unknown adults, receiving an Aim 1 recruitment card, who accept clinic-based HIV testing at the clinic screening visit. HIV testing will be done in accordance with Kenyan and Ugandan national testing algorithms. Uptake will be recorded on study CRFs.

  4. Yield of Adults With Untreated HIV

    Time frame: Measured at clinic screening visit

    The proportion of persons accepting HIV screening who are identified with newly diagnosed HIV or those who are self-reported to have known HIV infection but out of care and off of ART. HIV testing will be done in accordance with Kenyan and Ugandan national testing algorithms. Uptake, test results, HIV status, and current ART use will be recorded on study CRFs.

  5. Yield of Adults With Heavy Alcohol Use

    Time frame: Measured at clinic screening visit

    Heavy alcohol use is defined as self-reported AUDIT-C score (a standardized, three question survey) of greater than or equal to 4 for men and greater than or equal to 3 for women. These outcomes will be recorded on study CRFs.

  6. Adults With Untreated HIV Who Initiate ART

    Time frame: Measured within one week of presenting for clinic-based screening with a recruitment card

    The proportion of adults with untreated HIV that initiate ART. Current and prior ART use will be self-reported and recoded on study CRFs. New ART prescriptions will be measured through pill dispensing data and MoH registries.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Infectious Diseases Research Collaboration, Uganda
  • Kenya Medical Research Institute
  • Makerere University
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • University of California, Berkeley

Registry information

Official study title

Innovative Strategies to Promote Biomedical HIV Prevention Uptake and Retention Among High-risk Adults at Drinking Venues in Kenya and Uganda

Acronym: OPAL-Aim 1

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 17, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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